FDA 510(k) Obstetrics & Gynecology Devices
FDA 510(k) Obstetrics & Gynecology Devices - Regulatory Overview
FDA 510(k) obstetrics and gynecology (OB/GYN) devices include diagnostic and therapeutic equipment for women's reproductive health. The FDA review panel code is OB.
Key categories:
- Fetal monitoring systems - CTG monitors, fetal dopplers, scalp electrodes
- Intrauterine devices (IUDs) - hormonal and copper contraceptive devices
- Breast pumps and lactation aids - electric and manual breast pumps
- Gynecological surgical instruments - hysteroscopes, laparoscopic tools, ablation systems
- Pregnancy test systems - hCG detection devices for professional and home use
4507
Total
4493
Cleared
168d
Avg (2y)
1976
Since
3153 Obstetrics & Gynecology devices
Cleared
Jul 14, 2006
GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R
HET
Laparoscope, Gynecologic (and Accessories)
88d
Cleared
Jul 12, 2006
FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS
NUC
Lubricant, Personal
384d
Cleared
Jul 12, 2006
FEATHERLITE AQUA TOCODYNAMOMETER
HFM
Monitor, Uterine Contraction, External (for Use In Clinic)
89d
Cleared
Jul 07, 2006
EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01
KNA
Instrument, Manual, Specialized Obstetric-gynecologic
151d
Cleared
Jun 29, 2006
SONOHYSTEROGRAPHY BIOPSY DEVICE
PGK
Cannula, Injector, Uterine, Endometrial Biopsy
87d
Cleared
Jun 27, 2006
BOD POD
OAC
Plethysmograph, Air Displacement For Body Composition Analysis
91d
Cleared
Jun 09, 2006
TIPI
HHW
Pessary, Vaginal
102d
Cleared
Jun 08, 2006
DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS
NUC
Lubricant, Personal
146d
Cleared
May 25, 2006
40 L HIGH FLOW INSUFFLATOR F113
HIF
Insufflator, Laparoscopic
69d
Cleared
May 19, 2006
GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA
MQL
Media, Reproductive
150d
Cleared
May 10, 2006
SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)
MQL
Media, Reproductive
55d
Cleared
May 09, 2006
MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL
MQL
Media, Reproductive
140d
Cleared
May 09, 2006
PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
HIL
Tampon, Menstrual, Scented, Scented-deodorized
29d
Cleared
May 04, 2006
IGS VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
106d
Cleared
May 02, 2006
MEDELA SWING BREAST PUMP
HGX
Pump, Breast, Powered
183d
Cleared
Apr 24, 2006
VITRIFICATION FREEZE KIT, VITRIFICATION THAW KIT
MQL
Media, Reproductive
91d
Cleared
Apr 21, 2006
BURBANK TENACULUM
HDC
Tenaculum, Uterine
46d
Cleared
Apr 20, 2006
LADY COMP USA
LHD
Device, Fertility Diagnostic, Proceptive
461d
Cleared
Apr 14, 2006
GREEN LOVE MALE CONTRACEPTIVE (CONDOM)
HIS
Condom
281d
Cleared
Apr 14, 2006
FDS INTIMATE AND INTIMATE WARMING LUBRICANT
NUC
Lubricant, Personal
85d
Cleared
Apr 13, 2006
PICSI SPERM SELECTION DEVICE
MQK
Labware, Assisted Reproduction
218d
Cleared
Apr 10, 2006
FETAL ULTRASOUND AND TOCODYNAMOMETER TRANSDUCERS
HGM
System, Monitoring, Perinatal
374d
Cleared
Apr 07, 2006
NAKED
HIS
Condom
14d
Cleared
Apr 06, 2006
G-SPEC ARTICULATED WEIGHTED VAGINAL SPECULUM
HIB
Speculum, Vaginal, Nonmetal
216d
Cleared
Apr 04, 2006
DICK'S FORMALWEAR MALE LATEX CONDOM
HIS
Condom
357d
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